MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX; CLIP, IMPLANTABLE

Model Number CA500

Device Problem Migration (4003)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/15/2022

Event Type  Injury  

Event Description

Procedure performed: emergency laparotomy following a laparoscopic cholecystectomy.Event description: rep was not present for the case.During the initial laparoscopic cholecystectomy the surgeon reported that the case was completed without issue.He did not indicate that there were any issues with the clips.The patient was sent home then came back over the weekend needing an emergency laparotomy to address post-op bleeding.The second surgeon noted that there were 2500 ccs of blood in the patient's abdomen.The surgeon noted that 1-2 clips had come off the cystic artery.The surgeon was able to correct the bleeding and they are ok now.Patient status: patient is recovering after emergency laparotomy, they are ok now.Intervention: emergency laparotomy was performed to address post-op bleeding.

Manufacturer Narrative

The event unit is not anticipated to return to applied medical.A follow up report will be provided upon completion of the investigation.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the clip slippage was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of clip slippage.The probability and criticality of the harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: emergency laparotomy following a laparoscopic cholecystectomy.Event description: rep was not present for the case.During the initial laparoscopic cholecystectomy the surgeon reported that the case was completed without issue.He did not indicate that there were any issues with the clips.The patient was sent home then came back over the weekend needing an emergency laparotomy to address post-op bleeding.The second surgeon noted that there were 2500 ccs of blood in the patient's abdomen.The surgeon noted that 1-2 clips had come off the cystic artery.The surgeon was able to correct the bleeding and they are ok now.Product is not available for return.Additional information was received via email on 06oct2022 from billy weeks, applied medical account manager i."director of nursing stated with the patient having lost 2500ml they would have more than likely been transfused with 2 units.This has not been confirmed with surgeon on call, [name] [.] normal gallbladder case instruments bullet nose and [competitor brand] graspers as well as [competitor brand] mini metzenbaum scissors." no other information regarding the event is available.Patient status: patient is recovering after emergency laparotomy, they are ok now.Intervention: emergency laparotomy was performed to address post-op bleeding.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15537319
• MDR Text Key: 301111844
• Report Number: 2027111-2022-00757
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CA500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ALICE GRASPERS; CONMED MINI METZENBAUM SCISSORS
• Patient Outcome(s): Hospitalization; Other; Life Threatening